Ratiopharm
⚠️ Moderate Risk
FEI: 3004075481 • Mississauga, ON • CANADA
FEI Number
3004075481
Location
Mississauga, ON
Country
CANADAAddress
6975 Credit View R, , Mississauga, ON, Canada
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/13/2011 | 60MCY04DURAGESIC | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/26/2011 | 61TCY31DOMPERIDONE | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 11/2/2009 | 60MDA17OXYCODONE HCL (ANALGESIC, NARCOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/29/2005 | 61VIA99ANTI-FLATULENT N.E.C. | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 3/29/2005 | 61FCY54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/27/2004 | 61NCA78SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/27/2004 | 63BCN26IPRATROPIUM BROMIDE (BRONCHODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Ratiopharm's FDA import refusal history?
Ratiopharm (FEI: 3004075481) has 7 FDA import refusal record(s) in our database, spanning from 8/27/2004 to 12/13/2011.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Ratiopharm's FEI number is 3004075481.
What types of violations has Ratiopharm received?
Ratiopharm has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Ratiopharm come from?
All FDA import refusal data for Ratiopharm is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.